Methods and apparatus for performing valvuloplasty

ABSTRACT

The present invention relates to apparatus and methods for performing valvuloplasty. In some embodiments, the apparatus includes an expandable braid valvuloplasty device. In some embodiments, the methods and apparatus may be used as an adjunct to percutaneous heart valve replacement. In some embodiments, the apparatus and methods may provide a medical practitioner with feedback, monitoring or measurement information, e.g., information relevant to percutaneous transcatheter heart valve replacement.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 14/076,846,filed Nov. 11, 2013, now U.S. Pat. No. 9,358,106, which is acontinuation of application Ser. No. 11/314,969, filed Dec. 20, 2005,now U.S. Pat. No. 8,579,962, which claims the benefit of priority ofU.S. Provisional Application Ser. No. 60/724,455, filed Oct. 6, 2005,and is a continuation-in-part of application Ser. No. 10/982,692, filedNov. 5, 2004, now U.S. Pat. No. 7,824,442, which is acontinuation-in-part of application Ser. No. 10/746,120, filed Dec. 23,2003, which are incorporated herein by reference in their entirety andto which we claim priority under 35 USC .sctn..setn.119 and 120.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD OF THE INVENTION

The present invention relates to methods and apparatus for performingvalvuloplasty. More particularly, the present invention relates tomethods and apparatus for performing valvuloplasty as an adjunct topercutaneous transcatheter heart valve replacement.

BACKGROUND OF THE INVENTION

Failing heart valves can become calcified and stenotic. Valvuloplasty isa procedure that can break calcification and open up heart valves. Withthe advent of percutaneous transcatheter heart valve replacement(“PTVR”), the importance of valvuloplasty devices and procedures mayincrease, since a valvuloplasty procedure may be required to facilitatethe proper placement and/or expansion of a percutaneously deliveredvalve. Use of valvuloplasty in connection with PTVR is expected topresent unique challenges not previously addressed or accounted for bythe valvuloplasty prior art.

One problem associated with prior art balloon-based valvuloplastydevices is that the balloon may conform to the profile of the stenosednative valve, as opposed to forcing the stenosed valve to conform to adesired predetermined shape or profile of the balloon. Furthermore, someballoon-based valvuloplasty devices completely occlude the native valveand thereby stop the flow of blood during the valvuloplasty procedure.This severely limits the amount of time over which the procedure may bepracticed and brings additional risks to the already debilitatedpatient, thereby limiting the patient population on whom the proceduremay be performed.

Pedersen US 2005/0090846 is a balloon-based device that incorporates avalve within the balloon in order to maintain blood flow during thevalvuloplasty procedure. in such a device, the balloon may require arelatively large cross-sectional area in order to generate thesubstantial radial pressure against the native valve necessary toperform the procedure, thereby increasing its profile and reducing thepatient population in which the device may be utilized. As such, aballoon-based valvuloplasty device that incorporates a valve may onlypartially overcome the problem of flow occlusion during valvuloplasty,since its use may be limited by size constraints.

Another problem associated with prior art balloon-based valvuloplastydevices is the tendency of the valvuloplasty balloon to slip out of thestenotic area during the valvuloplasty procedure. Such slippage may, forexample, arise as a result of the pressures exerted on the device byblood ejected from the beating heart, or as a function of how thevalvuloplasty device inflates. A number of device designs have beenconceived to try to reduce or eliminate slippage. Some of these designsmake use of a shaped balloon in which a necked-in region is intended tointerface with the stenosed region of the native valve (see, forexample, PCT Publication No. WO 99/15223 to Cardeon Corporation,published Apr. 1, 1999). However, use of a valvuloplasty deviceincorporating a necked-in region requires precise placement of thevalvuloplasty balloon prior to inflation and may not adequately dilatethe target region. Other designs make use of an “ordered inflation”,wherein the balloon sequentially inflates, for example, with the distalend of the balloon beginning to inflate first, followed by inflation ofthe proximal end and final inflation of the center of the balloonpositioned across the native valve. See, e.g., Owens et al. U.S. Pat.No. 4,986,830.

An alternative prior art valvuloplasty technique, described, forexample, in U.S. Pat. No. 6,932,838 to Schwartz et al., utilizes anumber of “ribs” which, when constrained in such a way as to decreasethe distance between their proximal and distal ends, “bulge” radiallyoutward and apply radially outward-directed forces to the stenoticnative valve. These devices suffer from a number of shortcomings. Theminimal number of point contacts associated with the small number ofribs is expected to localize forces, thereby increasing the risk oflocalized tissue failure, e.g., perforation or dissection. Such devicesalso may he less efficient at transmitting the force provided by themedical practitioner into the radially- and outwardly-directed forcesnecessary for expansion of the native stenosed valve, as compared totraditional balloon valvuloplasty devices. Furthermore, these devicesmay require precise placement both axially and rotationally relative tothe stenotic native valve.

In view of the drawbacks associated with previously known methods andapparatus for performing valvuloplasty, it would be desirable to providemethods and apparatus that overcome those drawbacks. It also would bedesirable to provide methods and apparatus for performing valvuloplastythat address the unique challenges associated with using such methodsand apparatus as adjuncts to percutaneous transcatheter heart valvereplacement.

SUMMARY OF THE INVENTION

One aspect of the invention provides an apparatus for performingvalvuloplasty. The apparatus includes an expandable braid valvuloplastydevice; and a delivery system configured for percutaneous delivery,expansion and retrieval of the braid valvuloplasty device at avalvuloplasty site to perform a valvuloplasty procedure. In someembodiments, the apparatus may include a valve configured to regulateblood flow during the valvuloplasty procedure. In some embodiments, theapparatus may include one or more measurement elements for monitoringthe valvuloplasty procedure.

Another aspect of the invention provides a method for performingvalvuloplasty, the method including the steps of percutaneouslydelivering an expandable braid valvuloplasty device to a. valvuloplastysite within a patient, and temporarily expanding the expandable braidvalvuloplasty device to perform the valvuloplasty. In some embodiments,the method may include regulating blood flow in a vicinity of thevalvuloplasty site during the valvuloplasty. In some embodiments, themethod may include monitoring at least one characteristic of theexpandable braid valvuloplasty device during the valvuloplasty.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A and 1B are side views, partially in section, of valvuloplastyapparatus in accordance with the present invention;

FIGS. 2A-2G are side views, partially in section, illustrating a methodof using the apparatus of FIG. 1 to perform valvuloplasty;

FIG. 3 is a schematic side view, partially in section, of an alternativedelivery system for valvuloplasty apparatus of the present invention;

FIGS. 4A and 4B are schematic side-sectional detail views illustratingan embodiment of an optional valve utilized in combination withvalvuloplasty apparatus of the present invention;

FIGS. 5A and 5B are schematic side-sectional detail views illustratingan alternative embodiment of an optional valve utilized in combinationwith valvuloplasty apparatus of the present invention;

FIG. 6 is a schematic side-sectional detail view illustrating methodsand apparatus for interfacing valvuloplasty apparatus of the presentinvention with a delivery system;

FIG. 7 is a schematic side-sectional detail view illustratingalternative methods and apparatus for interfacing valvuloplastyapparatus of the present invention with a delivery system;

FIG. 8 is a schematic side-sectional detail view illustrating furtheralternative methods and apparatus for interfacing valvuloplastyapparatus of the present invention with a delivery system; and

FIG. 9 is schematic side-sectional view of a control assembly fordeploying and retrieving valvuloplasty apparatus of the presentinvention, the control assembly comprising measurement elements fordetermining information relevant to percutaneous transcatheter heartvalve replacement.

FIGS. 10A and 10B show details of a lockable expandable braid, with FIG.10B showing the expandable braid supporting a valve.

FIGS. 11A and 11B show details of a locking post for use with anexpandable and lockable braid having multiple lock positions.

FIGS. 12A and 12B show details of one embodiment of an actuator elementrelease mechanism for use with the invention.

DETAILED DESCRIPTION OF THE INVENTION

While preferred embodiments of the present invention are shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes and substitutions will now occur to those skilled inthe art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein in ay be employed in practicing the invention. it is intendedthat the following claims define the scope of the invention and thatmethods and structures within the scope of these claims and theirequivalents be covered thereby.

The present invention relates to methods and apparatus for performingvalvuloplasty. More particularly, the present invention relates tomethods and apparatus for performing valvuloplasty as an adjunct topercutaneous transcatheter heart valve replacement (“PTVR”), Such use inconnection with PTVR is expected to present unique challenges notpreviously addressed or accounted for by the prior art. For example, themedical practitioner may require additional feedback from the devicewhen performing the valvuloplasty procedure.

An important consideration when performing PTVR is correctly sizing thevalve implant to be used in the procedure. Characterization of valvesize may not he derived easily from standard visualization informationgenerally available to a physician at the time of valve implantation,e.g., from fluoroscopic imaging of the native valve. Furthermore, knownprocedures which could provide such information may be prohibitivelycostly, time-consuming and/or invasive.

Even if proper sizing information were derivable from standardvisualization information, such visualization information typicallywould provide no information on the stiffness of the native valve systemeither pre- or post-valvuloplasty. An expanded PTVR implant may rely, atleast to some extent, on counter forces provided by the surroundingtissue for proper anchoring and sealing function. Thus, the stiffness ofthe native valve system in the area of the implant may provide keyinformation to the practitioner useful, for example, in characterizationof proper implant size and/or implant stiffness. As such, avalvuloplasty system designed to provide information on appropriate PTVRimplant radial expansion forces and/or PTVR. implant size would providesignificant utility to the PTVR medical practitioner and patient.

With reference to FIG. 1, a first embodiment of a valvuloplastyapparatus in accordance with the present invention is described.Versions of this embodiment may also be used as a PTVR implant. Furtherdetails of this embodiment are described in Ser. No. 10/746,120, filedDec. 23, 2003, and Ser. No. 10/982,692, filed Nov. 5, 2004.

As illustrated by FIG. 1, valvuloplasty apparatus 10 includes anexpandable braid 30 and an optional valve 20. Apparatus 10 may becollapsed for delivery within a delivery system 100, as in FIG. 1A. Inthis embodiment, delivery system 100 illustratively includes a guidewire102 and a nosecone 104. Braid actuation elements 106 extending from amulti-lumen shall 108 connect apparatus 10 to the delivery system andmay be used to actuate apparatus 10, as described below. An externalsheath 110 is positioned over the shaft 108, and a control handle 120connects to shaft 108 at its proximal end. A proximal handle 111 movessheath 110 with respect to handle 120 and shaft 108. As shown in FIG.1A, apparatus 10 is collapsed for delivery with lumen 112 of externalsheath 110 distal of multi-lumen shaft 108.

In the embodiment shown in FIG. 1, some of the actuation elements 106are substantially stiff fingers extending between the distal end ofshaft 108 and the proximal end of braid 30, and some of the actuationelements are control wires (e.g., strands of suture, or metal or polymerwires) extending from actuators 122, 124 and/or 126 in control handle120 to the proximal ends of posts 32 attached to the distal end of braid30 via, e.g., one or more lumens of the multi-lumen shaft 108.Alternatively, the control wires may connect directly to the distal endof braid 30. Braid actuation elements 106 may be connected directly tothe valvuloplasty braid 30 in a manner that allows at least limitedrotation between the braid and the actuation elements during expansionof the braid.

As illustrated in FIG. 1, apparatus 10 may also include a valve 20within braid 30. Braid 30 can have closed ends (i.e., a continuouscircumference) at either or both of its ends but preferably at least inits proximal end. As shown in FIG. 1B, optional valve 20 is coupled tothe braid at posts 32. The optional posts can be attached to the braid'sdistal region, central region, or proximal region. Thus, optional posts32 may function as a valve support and may be adapted to support theoptional valve within the braid. In the embodiment shown, there arethree posts, corresponding to the valve's three commissure attachments.Optional valve 20 can be composed of a metal, a synthetic materialand/or may be derived from animal tissue. Valve 20 may be used toregulate blood flow during the valvuloplasty procedure. In embodimentsin which the device is used as a PTVR implant, valve 20 is thereplacement heart valve.

In some embodiments, braid 30 is collapsible and/or expandable and isformed from material such as Nitinol®, cobalt-chromium steel orstainless steel wire. For example, braid 30 may be self-collapsingand/or self-expanding and made out of shape memory material, such asNitinol®. A braid composed of shape memory material may self-expand toor toward its “at-rest” configuration after removal of an externalconstraint, such as sheath 110. This “at-rest” configuration of a braidcan be, for example its expanded configuration, its collapsedconfiguration, or a partially expanded configuration (between thecollapsed configuration and the expanded configuration). In someembodiments, a braid's at-rest configuration is between its collapsedconfiguration and its expanded configuration. Depending on the “at-rest”diameter of the braid and the diameter of the patient's anatomy at thechosen deployment location, the braid may or may not self-expand to comeinto contact with the diameter of the patient's anatomy at that locationupon removal of an external constraint. Further details regarding thebraid, valve and delivery system may be found in Ser. No. 10/746,120,filed Dec, 23, 2003, and Ser. No. 10/982,692, filed Nov. 5, 2004.

During a valvuloplasty procedure, braid 30 may be expanded to a fullydeployed configuration from a partial deployed configuration (e.g., aself-expanded or at-rest configuration). in the embodiment shown in FIG.1, the braid 30 is expanded actively, e.g., by actively foreshorteningbraid 30 during endovascular deployment. Active foreshortening isdescribed in more detail in U.S. patent application Ser. No. 10/746,120.During active foreshortening, the distal region of braid 30 is pulledproximally via a proximally-directed force applied to posts 32 via,e.g., actuation control elements and/or control wires connected to thedistal region of the braid. Actuation control elements engaged with theproximal end of braid 30 provide a distally- directed counter-force tothe proximally directed force. The proximally- and distally-directedforces applied to the distal and proximal regions, respectively, of thebraid foreshorten the braid and expand it radially.

In some embodiments, active foreshortening of the apparatus involvesapplying a proximally-directed force on a deployment system interface atthe distal end of the braid, while maintaining the proximal end of thebraid in the same location. in other embodiments, foreshortening of theapparatus involves applying a distally-directed force on proximal end ofthe braid (e.g., by applying a distally-directed force on the braidactuation elements) while maintaining the distal end of the braid in thesome location. in still other embodiments, a distally-directed force isapplied to the proximal end of the braid, while a proximally-directedforce is applied to the distal end of the braid.

The actuation elements (e.g., fingers, tubes, posts, and/or controlwires connecting to posts), such as braid actuation elements 106, arepreferably adapted to expand radially as the braid expands radially andto contract radially as the braid contracts radially. Furthermore,proximally- or distally-directed forces applied by actuation elements onone end of the braid do not diametrically constrain the opposite end ofthe braid. In addition, when a proximally- or distally-directed force isapplied on the braid, it is preferably applied without passing anyportion of the actuation elements through a center opening of theoptional valve. This arrangement enables the valve to operate dun rigvalvuloplasty

The active expansion of the braid optionally may be assisted viainflation of a balloon catheter (not shown) reversibly disposed withinapparatus 10, as described in previously incorporated U.S. patentapplication Ser. No. 10/746,120. However, expansion without use of aballoon catheter is preferred such that flow is never occluded duringdeployment.

With reference to FIG. 2, in conjunction with FIG. 1, apparatus 10 maybe utilized to perform valvuloplasty, e.g., aortic valvuloplasty. Suchvalvuloplasty may be utilized as an adjunct to PTVR. As seen in FIG. 2A,apparatus 10 may be advanced in a retrograde fashion through aorta Aover guidewire 102 and placed across a patient's stenosed aortic valveAV using well-known percutaneous techniques. During delivery, apparatus10 is positioned in the reduced delivery configuration within deliverysystem 100, as described with respect to FIG. 1A. Once positioned acrossthe stenosed valve, external constraint may be partially removed fromapparatus 10, for example, by retracting proximal handle 111 of sheath110 relative to control handle 120, thereby retracting sheath 110relative to apparatus 10 (handle 111 is positioned external to thepatient). As seen in FIG. 2B, braid 30 of apparatus 10 begins toself-expand to the at-rest configuration. As seen in FIGS. 2C and 2D,apparatus 10 may be repositioned via delivery system 100 until thepartially expanded distal region of the apparatus contacts the valveannulus, thereby ensuring proper positioning prior to completion of thevalvuloplasty procedure.

Once properly positioned, further retraction of sheath 110 fully removesthe external constraint from apparatus 10 such that braid 30 assumes theat-rest configuration, as seen in FIGS. 2E and 2F. If present, optionalvalve 20 regulates blood flow through the device to ensure continuousperfusion of the patient both during deployment and retrieval of theapparatus, as well as during the actual valvuloplasty. Braid 30 then maybe actively expanded, as described previously with respect to FIG. 1B,to the configuration of FIG. 2G, such that apparatus 10 applies aradially outward force to the native valve to perform the valvuloplastyand restore adequate flow through the patient's native valve. Aftercompletion of the valvuloplasty procedure, apparatus 10 may again bepositioned within lumen 112 of sheath 110, for example by retractingmulti-lumen shaft 108 and apparatus 10 relative to sheath 110. Braidactuation elements 106 provide a smooth transition that progressivelycollapses braid 30 and allows apparatus to be re-positioned within lumen112 of sheath 110. Once fully collapsed, apparatus 10 and deliverysystem 100 may be removed from the patient.

Use of valvuloplasty apparatus 10 provides a number of advantages overknown valvuloplasty devices. For example, use of braid 30 with optionalvalve 20 provides a large, unobstructed cross-sectional area for bloodflow, while additionally providing valve function during thevalvuloplasty procedure. Thus, the duration of the valvuloplastyprocedure is not limited by loss of blood flow, as are procedures usingfully occlusive or less occlusive, but valveless, valvuloplasty devices.This allows for more accurate and careful positioning of the deviceprior to and during the expansion process. Additionally, since bloodflow is not stopped during the procedure, the procedure can be performedon patients who otherwise would be considered too ill to survive such aprocedure.

Positioning of a valvuloplasty device should be affected only minimallyby blood ejected from the beating heart. The relatively low occlusivecross-sectional area of apparatus 10 is expected to reduce forcesexerted on the apparatus by blood passing through the aortic valve,thereby decreasing the force necessary to maintain the apparatus inplace during the procedure, as compared to some known valvuloplastydevices. Thus, the likelihood that apparatus 10 will undesirably migrateduring the procedure is expected to be reduced relative to currenttechniques. Furthermore, the relative roughness of the outer surface ofbraid 30, as compared to the roughness of traditional balloonvalvuloplasty devices, also is expected to hold apparatus 10 in placeand reduce the likelihood of slippage or migration during expansion ofthe apparatus.

As another advantage, apparatus 10 having braid 30, either with orwithout optional valve 20, is expected to provide a more uniformdistension to the native stenosed valve than would be provided by eithera balloon-based or a ribbed valvuloplasty device. Braid 30 is expectedto force the native valve to conform to the shape of the foreshortenedand radially expanded braid. Expansion of the braid is expected toimpart a roughly cylindrical distension to the native valve tissue; whenutilized as an adjunct to PTVR, this roughly cylindrical shape mayapproximate the shape of the intended implant.

Apparatus 10 also provides an inherent mechanical advantage to thetransmission of force to the patients native valve, as compared toribbed valvuloplasty devices. Ribbed devices take a certain amount offorce to bend, in addition to the force necessary to displace the nativevalve. Additionally, since the forces will be concentrated on a limitednumber of ribs, the stresses on these ribs will be concentrated therebyincreasing the risk of failure. As another advantage, apparatus 10 isexpected to have a relatively low profile delivery configuration, ascompared to balloon valvuloplasty devices that include a central valve.

The manner in which apparatus 10 is deployed (i.e., activeforeshortening of braid 30 via. delivery system 100) may provide amedical practitioner with tactile or force feedback informationindicative of calcific cracking along the calcified aortic valve. Thisis in contrast to inflation of a balloon valvuloplasty device, which maynot provide the medical practitioner with adequate tactile informationrelated to calcific cracking. Optionally, the force applied by themedical practitioner during deployment of apparatus 10, as well as theresultant foreshortening of braid 30, may be measured or monitored toprovide a force vs. distension curve that is indicative of calcificcracking.

Given the short-term use of apparatus 10, simplified embodiments of theapparatus and/or of delivery system 100 may be provided. Someembodiments may, for example, incorporate control elements that passthrough or are positioned within the center of the apparatus. Otherembodiments may not include optional valve 20. With reference to FIG. 3,alternative delivery system 200 suitable for delivering, deploying andretrieving valvuloplasty apparatus 10 is described. In FIG. 3, apparatus10 illustratively does not have a valve.

Delivery system 200 has an outer shaft 210 coupled to a proximal regionof apparatus 10, as well as an inner shaft 220 that passes through thelumen of apparatus 10 and is coupled to a distal region of theapparatus. The inner and/or outer shafts may he connected directly toapparatus 10; alternatively, the inner and/or outer shafts may beconnected to the apparatus through an intermediary element configuredfor radial expansion. Inner shaft 220 is coaxially disposed within outershaft 210. The inner shaft terminates at nosecone 222 and preferably hasa guidewire lumen (not shown). As in the embodiment of FIG. 1, deliverysystem 200 may also have an outer sheath (not shown) that constrainsapparatus 10 in a reduced configuration during delivery and retrievalfrom a valvuloplasty site.

Delivery system 200 has a control assembly 230 having handle 240 andtrigger 250. Trigger 250 is pivotably connected to handle 240 at pivot242. Furthermore, trigger 250 is connected to inner shaft 220, whilehandle 240 is connected to outer shaft 210. As trigger 250 is pulledtowards handle 240, inner shaft 210 is retracted proximally relative toouter shaft 220 such that the distance between the distal ends of theinner and outer shafts is decreased. Since the inner and outer shaftsare respectively coupled to the distal and proximal regions of apparatus10, braid 30 is foreshortened and increases in diameter. This diametricexpansion may be utilized to perform vat valvuloplasty, as describedpreviously.

In embodiments of apparatus 10 that include the optional valve, thevalve may comprise any of a variety of alternative valve designs. FIGS.4 and 5 describe two such valve design embodiments. These embodimentsare provided only for the sake of illustration and should in no way beconstrued as limiting; additional embodiments within the scope of thepresent invention will be apparent to those of skill in the art in viewof this disclosure. In the embodiment of FIG. 4, valve 20 is centrallymounted within apparatus 10, e.g., is circumferentially coupled to innershaft 210 of delivery system 200. FIG. 4A shows apparatus 10 in theat-rest configuration, while FIG. 4B shows the apparatus in the expandeddeployed configuration for performing valvuloplasty. In eitherconfiguration, as well as during transition between the twoconfigurations, blood flow may pass through apparatus 10 along the outercircumferential edge of valve 20 between the valve and braid 30.

In the embodiment of FIG. 5, valve 20 is mounted along the perimeter ofapparatus 10, e.g., is coupled to braid 30, and has its opening in themiddle of the apparatus. FIG. 5A shows apparatus 10 in the at-restconfiguration, while FIG. 5B shows the apparatus in the expandeddeployed configuration for performing valvuloplasty. In eitherconfiguration, as well as during transition between the twoconfigurations, blood flow may pass through apparatus 10 through thecenter of valve 20. When valve 20 has a central opening as in FIG. 5,the valve may, for example, be configured as a single cusp, as multiplecusps, or as a spiral-shaped valve. In a preferred embodiment, the valveis a tricuspid valve. When spiral-shaped, the valve may, for example,comprise a strip of material that forms a helix on or along the innerdiameter of the braid. The strip of material preferably is wide enoughsuch that it is able to coapt against itself or against a central lumenor wire, such as a guidewire.

The apparatus optionally may have a seal that separates the interior ofthe apparatus from its exterior, e.g., that seals the openings in braid30, such as seal 29 in FIG. 10B. The seal preferably is configured toexpand with the braid. In use during valvuloplasty, the seal-mayfacilitate sealing of the patients native valve against the outside ofthe apparatus, while valve 20 functions within the interior of theapparatus. In this manner, the apparatus regulates blood flow during thevalvuloplasty procedure, while reducing or eliminating uncontrolledleakage around the outside of the apparatus.

Referring now to FIGS. 6-8, the distal and proximal edges of braid 30 ofapparatus 10 may be interfaced with a delivery system in a variety ofways in order to facilitate foreshortening, and thereby radialexpansion, of the braid and of the apparatus. The exemplary embodimentsof FIGS. 6-8 are provided only for the sake of illustration and shouldin no way be construed as limiting. Additional methods and apparatuswithin the scope of the present invention for interfacing braid 30and/or apparatus 10 with a delivery system will be apparent to those ofskill in the art in view of this disclosure.

In FIG. 6, delivery system 300 has a plurality of relatively stiffelements 302 coupled to both the distal and proximal ends of braid 30.In use, braid 30 may be foreshortened by applying a proximally directedforce on the elements 302 coupled to the distal end of braid 30 and adistally directed force on the elements 302 coupled to the proximal endof braid 30. Elements 302 move radially with the braid during expansionand contraction of the braid.

In FIG. 7, stiff elements 302 are coupled to the proximal end of braid30, while flexible control wires 304 are coupled to the distal end ofthe braid. Once again, braid 30 may be foreshortened by applying aproximally directed force on the control wires 304 and a distallydirected force on the elements 302 coupled to the proximal end of braid30.

in FIG. 8, delivery system 300 once again has relatively stiff elements302 that are coupled to both the proximal and distal ends of braid 30.However, in the embodiment of FIG. 8, the distal elements 302 are placedin compression rather than in tension during foreshortening of braid 30and expansion of apparatus 10.

When used, for example, as an adjunct to PTVR, apparatus 10 and/or thedelivery system may provide information useful in preparing for a PTVR.procedure. For example, the apparatus and/or the delivery system mayprovide information useful in characterizing the implant size suitablefor a particular patient. The apparatus and/or the delivery system mayincorporate elements for measuring diameter and/or for quantifyingradial expansion forces at the location intended for the implant.

Measurement of the expanded diameter of braid 30 during thevalvuloplasty procedure (and thereby measurement of, e.g., the propersize for a PTVR implant) may be derived from measurement of linearforeshortening of the braid. The relationship between diameter andlinear foreshortening depends on the particular design of braid 30.However, the relationship can be well understood and or empiricallycharacterized for any given design. In some embodiments, therelationship between the length of braid 30 and the diameter of thebraid can be approximated by the relationship:

D:=n(1.sup.2).sup.1/2pi   (1)

here D is the diameter of the braid, 1 is the length of the braid, and Kand n are constants specific to the design of the braid. In otherembodiments K may also vary as a function of a braid characteristic,such as length.

When implanting a replacement heart valve, it may be important to ensurethat the anchoring force—i.e., the force exerted by the replacementvalve on the patient's tissue, which equals the force applied by thetissue on the native valve is sufficient to prevent migration of theimplant valve after implantation. The force that will be applied to thepatient's tissue by a replacement valve and anchor expanded to aparticular diameter may also be determined by the device of thisinvention. This combination of diameter and radial force at thatdiameter helps determine the size PTVR implant to use and/or the size towhich an adjustably sized implant should be expanded. The radialexpansion force applied to the patient's native valve and/or valveannulus during deployment of braid 30 (and thereby measurement of, e.g.,the proper stiffness or expansion force for a PTVR implant) is relatedto the force exerted to foreshorten braid 30. As with the diametermeasurement, the relationship between foreshortening force and radialexpansion force depends on the particular design of the braid. However,for a given design, the relationship can be well understood andempirically characterized.

Referring now to FIG. 9, control assembly 400 for deploying andretrieving valvuloplasty apparatus 10 is described. In this embodiment,the control assembly has measurement elements for determininginformation relevant to percutaneous transcatheter heart valvereplacement. When used in combination with a delivery system, controlassembly 400 is configured to measure the diameter of braid 30, as wellas to determine the radial expansion force applied by the braid, duringvalvuloplasty with apparatus 10 at a location intended for subsequentplacement of a PTVR implant. Control assembly 400 may be used inconjunction with any of the previously described delivery systems orwith any other delivery system capable of delivering, deploying andretrieving apparatus 10. In FIG. 9, control assembly 400 illustrativelyis used in conjunction with delivery system 200 of FIG. 3, with controlassembly 400 utilized in place of previously described control assembly230. As described previously with respect to FIG. 3, the proximal regionof apparatus 10 may be coupled to the distal end of outer shaft 220,while the distal region of the apparatus may be coupled to distal end ofinner shaft 210.

When positioned at a valvuloplasty site, foreshortening of braid 30 ofapparatus 10 may be achieved by squeezing trigger 408 such that itrotates about pivot 415 relative to handle 414. This proximally retractsratchet element 405 relative to control assembly 400 via co-actionbetween the ratchet and element 409 of the trigger. Element 409 isrotationally constrained around pivot 415 in the clockwise directionfrom its shown at-rest position. This movement retracts inner shaft 210of delivery system 200 relative to outer shaft 220, thereby expandingapparatus 10. Spring-loaded tab 407 restrains ratchet 405 from slippingback to its original position in order to maintain the expansion ofapparatus 10.

Control assembly 400 comprises a load-sensing capability anddisplacement-sensing capability. These two parameters provideinformation relating to the radial stiffness and to the diameter of thenative valve or valve annulus. When ratchet element 405 is moved in theproximal direction, it transmits force through spring 412 to inner shaft210 to move the inner shaft proximal relative to outer shaft 220.Diameter indicator needle 411, which is coupled to the proximal end ofinner shaft 210, and displacement display 403 indicate the magnitude ofdisplacement of inner shaft 210 relative to outer shaft 220. Since theouter shaft is coupled to the proximal region of apparatus 10 and theinner shaft is coupled to the distal region of the apparatus, thisdisplacement measurement is indicative of the amount that braid 30 hasforeshortened. As discussed previously, the diameter of apparatus 10 maybe derived from measurement of linear foreshortening. In someembodiments, display 403 may be calibrated to the diameter of braid 30or apparatus 10 such that indicator needle 411 provides a measurement ofthe diameter of apparatus 10. This diameter measurement may be used,e.g., to determine the size of a PTVR implant.

For measurement of radial expansion force, ratchet element 405, which iscoupled to the proximal end of spring 412, may be read against loaddisplay 402. As spring 412 is urged proximally, load display 402 alsomoves in the proximal direction. The load or force necessary to sustainforeshortening of braid 30 and expansion of apparatus 10 is supported byspring element 412, which stretches in a characterizable amount inaccordance with the magnitude of the load. For a standard spring thisrelationship is governed by Hooke's Law:

F=kx   (2)

where F is the load or force supported by the spring, k is the springconstant (per se known), and x is the linear displacement or amount of“stretch” in the spring. This amount of “stretch” is indicated by therelative movement between load indicator needle 410, which is coupled toinner shaft 210 (illustratively via diameter indicator needle 411) andload display 402. The load display preferably is calibrated in loadunits, such that load indicator needle 410 provides a. measurement ofradial expansion forces. This measurement may be used, e.g., to select aPTVR implant of proper radial stiffness and diameter.

The above displacement-sensing capability also may be facilitated by anumber of alternative means, including, but not limited to, linearencoders, rotary encoders in association with rotary to linear motionconverters, linear variable displacement transformers (“LVDTs”), etc.Furthermore, the load sensing capability may be replaced by a load cell.In some of these alternate embodiments the load and displacementdisplays may be an electronic display which is capable of displayingoutputs in real time. Such outputs may additionally be stored internallyand or transmitted to other digital devices. Additionally, such displaysmay provide a graphic representation of both load and diameter.

In other embodiments, the replacement valve itself may be used toperform valvuloplasty prior to implantation. For example, the braid 30and valve 20 of FIG. 1 may be expanded within the native valve throughactive foreshortening, as described above. The diameter and forcemeasurement gauges of FIG. 9 may be employed to indicate the amount ofexpansion achieved and the amount of force applied to the native valve.After performing valvuloplasty, the apparatus may be left behind tofunction as a replacement heart valve instead of being removed from thepatient as discussed above.

In some embodiments, the braid of the replacement valve apparatus may belocked in an expanded condition. One example of a locking braid is shownin FIG. 10. In this embodiment, openings are formed at the top end ofposts 32. These openings engage buckles 34 when the braid isforeshortened to form a lock 40. Other locking anchor apparatus may beused, such as those described in Ser. No. 10/746,120, filed Dec. 23,2003, and Ser. No. 10/982,692, filed Nov. 5, 2004.

When a replacement valve apparatus with a locking anchor is used toperform valvuloplasty, it may be desirable to use an anchor that can belocked in multiple expanded diameters. For example, when the desiredamount of expansion and expansion force has been achieved, the braidedanchor may be locked in that diameter. One example of a post and bucklearrangement with multiple locking locations is shown in FIG. 11. In thisembodiment, post 32 has multiple arrowhead shaped locking elements 46with resilient or shape memory appendages 48 extending from them. In theunlocked configuration shown in FIG. 11A, an overtube 47 extendingthrough buckle 42 prevents appendages from engaging buckle 42 asactuation element 106 b pulls post 32 proximally into and through buckle42. When overtube 47 is withdrawn (controlled, e.g., by an actuator onthe proximal handle of the delivery system), appendages 48 move outwardto engage buckle 42 and lock the anchor in its expanded configuration.Other multiple position anchor locks are described in Ser. No.10/746,120, filed Dec. 23, 2003, and Ser. No. 10/982,692, filed Nov. 5,2004.

Also, when a replacement valve and anchor is used to performvalvuloplasty, the delivery system must have some way of releasing thevalve and anchor at the completion of the deployment and implantationprocedure. FIG. 12 show an example of a release mechanism using anovertube 310 surrounding actuation element 106 b. In FIG. 12A, thedistal end 330 of actuation element 106 b forms a hook 332 that passesthrough a hole 320 formed in the end of post 32. Withdrawal of overtube310 (controlled, e.g., by an actuator on the proximal handle of thedelivery system) permits actuation element 106 b to straighten andwithdraw from hole 320, as shown in FIG. 12B, thereby releasing post 32from the deliver y system. Similar release actuation mechanisms can beused for actuation elements controlling force delivered to the proximalend of the anchor. Other actuation element release mechanisms aredescribed in Ser. No. 10/746,120, filed Dec. 23, 2003, and Ser. No.10/982,692, filed Nov. 5, 2004.

What is claimed is:
 1. A replacement heart valve comprising: anexpandable anchor comprising a frame and a plurality of commissureattachment sites, the expandable anchor having a distal end, the framedefining a plurality of cell openings, and each of the commissureattachment sites defining at least one hole therethrough; a tricuspidvalve attached to the expandable anchor at the commissure attachmentsites; and a seal extending along at least a portion of the frame, theseal being configured to cover at least some of the plurality of cellopenings.